Dr. Markus Yap, visiting assistant professor inthe George Washington University’s (GW) online Master of Science in Health Sciences (MSHS) in Regulatory Affairs, provides industry and career insights for prospective regulatory affairs students.
How did you enter the regulatory affairs field, and what led you on this career path?
In 2009, I was inspired by President Obama’s call to engage in public service and joined the FDA as a Commissioner’s Fellow. It was a two-year intensive program for PhD/MD scientists and physicians to train in regulatory science and learn FDA’s inner workings. After graduation, I held several roles at the FDA, including as a Reviewer, Business Informatics Manager, Branch Chief for Nuclear Medicine and Radiation Therapy and Deputy Director for International Compliance.
Since the start of my career, I have been intimately familiar with FDA requirements and admired the agency greatly. Prior to joining the FDA, I spent almost 20 years in the life sciences industry working in R&D, engineering, business development, clinical affairs, marketing and product management.
During my time at the FDA, I earned a Master of Public Health at Harvard University. Prior to that, I earned a Bachelor’s in Chemistry from Occidental College; a Master’s in Electrical Engineering from Caltech; a PhD in Bioengineering completed at Caltech, Stanford University and University of Illinois Chicago; and an MBA in Finance and Marketing with a Certificate in Health Administration and Policy from the University of Chicago’s Booth School of Business.
How have you been able to apply your professional experience to the classroom environment?
My work as a reviewer for the FDA was very valuable; I had to look at different marketing approval submissions and make judgments, which is how you really learn. I think learning from faculty who actively practice in regulatory affairs and conduct research in regulatory science provides an optimal learning experience for our students since many of them already work in the industry and enroll in the program to formalize and refine their skills and training.
My practical experiences working both in the industry and for the FDA provide a basis for many lectures, discussion topics and assignments in my classes – providing a tremendous value to my students.
What are some of the challenges facing the regulatory industry today?
The primary challenge has always been finding a balance between efficacy (promoting innovative medical products) and safety (protecting public health through assurances that medical products approved are indeed safe). We are in the second decade post-completion of the Human Genome Project and well into the era of personalized medicine in which drugs may be custom-tailored for specific patient populations. It is an exciting time but also a time of many moving unknown variables — including the potential of cutting-edge science and technology for drug innovation, replacing the blockbuster drug model, the potential repeal of the Affordable Care Act and the FDA’s changing views on risk — all of which are typical during a change in administration and appointment of a new FDA Commissioner.
Like in any other industry, challenges often bring opportunities for those who are in the position to capitalize. In the past, regulatory affairs activities were seen as a cumbersome but necessary afterthought once the product was developed. These days, a carefully planned regulatory strategy for a product’s entire lifecycle is considered a must. This is the golden era for regulatory affairs professionals — especially in the drug and device industry — to rise to the challenge and distinguish themselves.
Regulatory Affairs Professionals now have a path to becoming C-level executives, which did not exist in the past. It provides an incentive for our students to learn business skills and interdisciplinary skill sets related to the regulatory affairs function. Recently, GWU faculty in the Regulatory Affairs program published a paper that proposed advancement of the concepts aforementioned, “Increasing the Odds of Effective Drug Development: Elevating Regulatory Affairs Professionals to Strategic Partners,” Clinical Research and Regulatory Affairs, 2016.
What is one thing that current students might be surprised to learn about the industry?
In the past, it was notoriously hard to break into the field of regulatory affairs. Many professionals entered the field after becoming an expert in another function, such as R&D or manufacturing. Often, a regulatory affairs job fell in to their lap because they had the best knowledge of the product in development, but not necessarily because of their regulatory science knowledge.
These days, with the increased availability of graduate programs in Regulatory Affairs, such as at GW, professionals can specifically be trained in Regulatory Science, while honing their skills in the industry. In essence, there is now an established career path to become a Regulatory Affairs Professional.
What are the job opportunities in Regulatory Affairs? What type of educational or professional background would be beneficial to someone looking to enter this field?
There are basically two options for getting a job in regulatory affairs: working for drug/device/biotech companies or joining the FDA as a staff reviewer. The former is much more common. There is also the opportunity to look beyond strict regulatory affairs functions by working in business development, marketing, clinical trials and manufacturing roles, especially at start-ups where wearing multiple hats is common.
Many successful regulatory affairs professionals come from R&D and/or manufacturing backgrounds, which makes it easier to understand the science and technology behind innovative drugs and devices, as well the quality aspects of manufacturing. However, many come from other backgrounds and have picked up sufficient relevant science and technology knowledge on the job. Successful regulatory affairs professionals most often display a good balance between IQ (intellectual quotient) and EQ (emotional quotient) skill sets.
How does GW’s Regulatory Affairs curriculum prepare students to advance in the field?
The curriculum is comprehensive because the foundations of regulatory science — such as epidemiology, biostatistics and clinical trials — are built into the program and combined with leadership training. Students are required to take classes in each of the medical product categories (e.g., drugs, biologics, devices and diagnostics) as well as the product management lifecycle (pre-market and post-market/compliance).
In addition, GW’s regulatory affairs program is unique because it is housed in GW’s School of Medicine and Health Sciences, known for its’ legacy of preparing leaders on the cutting edge of health care. Located in Washington, D.C., at the hub of international science, health policy and business, GW provides access to renowned experts and institutions in the field through the program’s faculty and industry collaborators.
In your opinion, what sets GW’s Regulatory Affairs program apart from similar programs?
GW’s Regulatory Affairs program is well-known among working professionals in the industry because of its interdisciplinary approach and comprehensive curriculum and the qualifications of its practitioner faculty.
What advice would you give to current students or alumni?
Aside from regulatory science, students should take advantage of opportunities to widen their horizon in related fields like business development, finance, marketing or clinical trials. It will serve them well as they climb up the proverbial career ladder to the C-level executive suite.
For more information on the George Washington University’s online Master of Science in Health Sciences (MSHS) in Regulatory Affairs, contact an admissions advisor today at (844) 386-7323 or click here to request more information.